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REVISTA DE PATOLOGÍA RESPIRATORIA
Volumen 24 • Número 4 • Octubre-Diciembre 2021
ORIGINAL ARTICLE
PIMA Study. Improvement of adherence and quality of life of
obstructive sleep apnea under CPAP treatment through an
intervention based on the stratifcation and personalization of care
plans: a randomized controlled trial
D. Rudilla
1
, S. Perelló
2
, P. Landete
3
, E. Zamora
3
, M. Vázquez
4
, Ll. Sans
2
, J.M. Tomás
5
, G. Rubinos
4,
*,
J. Ancochea
3,
*
1
Air Liquide Healthcare – Hospital Universitario de La Princesa. Madrid, Spain.
2
Hospital Universitario Joan XXIII. Tarragona, Spain.
3
Hospital Universitario de La Princesa. Madrid, Spain.
4
Hospital Universitario Central de Asturias. Oviedo, Spain.
5
University of Valencia.
Valencia, Spain. *Shared last authorship.
Rev Patol Respir. 2021; 24(4): 125-134
Correspondencia:
David Rudilla, PhD. C/ Orense, 34, 3-1. 28004 Madrid (Spain). E-mail: david.rudilla@airliquide.com
Recibido:
29 de octubre de 2021;
Aceptado:
22 de diciembre de 2021
Abstract
Introduction
. The frst-line treatment for obstructive sleep apnea (OSA) is continuous positive airway pressure (CPAP)
therapy. Lack of adherence is the main problem with CPAP. A motivated patient is needed. The objective of this study is to
determine adherence to CPAP and health-related outcomes in patients with OSA through a comprehensive program based on
stratifcation and individualized care plans, using motivational interviewing.
Methods
. Multicenter randomized controlled trial (RCT) conducted in 3 hospitals. Control group followed the usual treatment.
Intervention group (PIMA) followed the treatment with an adapted care based on sociodemographic, clinical and psychological
variables, using motivational interview. The main outcome was adherence (90 and 180 days of treatment), and the secondary
outcomes were quality of life, emotional state, activities, social relationships, perceived competence, and motivation.
Results
. 213 patients were randomized (intervention group: 108; control group: 105). A statistically signifcant difference
was found in the intervention group versus the control group in adherence at 90 and 180 days: 129.24 (IC95% 77.25-181.22)
p< 0.0001 and 288.30 (IC95% 187.146-389.47) p< 0.0001. Adherence (hours/day) was higher in the PIMA group compared
to the control group at 90 days with a difference of 1.74 hours/day (IC95% 1.18-2.30) p< 0.0001 and at 180 days with a dif
-
ference of 2.31 (IC95% 1.72-2.91) p< 0.001. The secondary results showed signifcant differences in favour of the PIMA group.
Conclusions
. Evidence was found that a program based on stratifcation and personalized care plans, using motivational
interviewing, improves adherence to CPAP and quality of life.
Key words:
Adherence; CPAP; Quality of life; RCT; Obstructive sleep apnea; Stratifcation.
ESTUDIO PIMA. MEJORA DE LA ADHERENCIA Y DE LA CALIDAD DE VIDA DE LA APNEA OBSTRUCTIVA DEL
SUEÑO EN TRATAMIENTO CON CPAP A TRAVÉS DE UNA INTERVENCIÓN BASADA EN LA ESTRATIFICACIÓN Y
PERSONALIZACIÓN DE LOS PLANES DE ATENCIÓN: UN ENSAYO CONTROLADO ALEATORIZADO
Resumen
Introducción
. El tratamiento de primera línea para la apnea obstructiva del sueño (AOS) es la terapia de presión positiva
continua en las vías respiratorias (CPAP). La falta de adherencia es el principal problema de la CPAP. Se necesita un paciente
motivado. El objetivo de este estudio es determinar la adherencia a la CPAP y los resultados relacionados con la salud en pa
-
cientes con AOS a través de un programa integral basado en estratifcación y planes de atención individualizados, utilizando
entrevista motivacional.
Métodos
. Ensayo controlado aleatorizado multicéntrico realizado en 3 hospitales. El grupo de control siguió el tratamiento
habitual. El grupo de intervención (PIMA) siguió el tratamiento con un plan de cuidados adaptado basado en variables socio
-
demográfcas, clínicas y psicológicas, utilizando entrevista motivacional. El resultado principal fue la adherencia (90 y 180
días de tratamiento) y los secundarios fueron la calidad de vida, el estado emocional, las actividades, las relaciones sociales,
la competencia percibida y la motivación.
Resultados
. Se aleatorizaron 213 pacientes (grupo PIMA: 108; grupo de control: 105). Se encontró una diferencia estadís
-
ticamente signifcativa en el grupo PIMA versus el grupo control en la adherencia a los 90 y 180 días: 129.24 (IC95% 77.25-
181.22) p < 0.0001 y 288.30 (IC95% 187.146-389.47) p < 0.0001. La adherencia (horas/día) fue mayor en el grupo PIMA
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Introduction
Obstructive sleep apnea (OSA) is a common sleep dis
-
order, characterized by repeated pauses in breathing during
sleep. It is a chronic condition affecting nearly one billion
adults worldwide, with nearly half requiring treatment based
only on OSA severity
1
. OSA is defned by the presence of at
least fve obstructive respiratory events per hour of sleep
and the presence of symptoms such as daytime sleepiness,
snoring, witnessed breathing interruptions, awakenings due
to gasping or choking, resistant hypertension, or reduced
sleep- related quality of life
2
. Daytime sleepiness is often
prioritized due to immediate safety risks, as individuals
with untreated OSA are 243% more likely to have a motor
vehicle accident than drivers without OSA
3
. In addition to
excessive daytime sleepiness
4
and increased risk of mo
-
tor vehicle accidents
5
, untreated OSA is associated with
additional adverse daytime symptoms including impaired
cognitive performance
6
, and mood disturbances
7
. It is also
associated with negative health consequences, including car
-
diovascular disease and hypertension
8
, diabetes
9
, stroke
10
,
and death
11
. Continue
Positive airway pressure (CPAP) ther
-
apy is an effcacious treatment for OSA
12
. CPAP treatment is
behaviourally based and requires the individual with OSA to
wear PAP every night. Most research considers a patient who
uses CPAP a minimum of 4 hours a night during 70% of the
week to be a good complier
13
. Multidisciplinary approaches
based on the study of behavioural changes together with
continuous monitoring have shown promising results in im
-
proving patient adherence to CPAP intervention
14,15
. Patients
may beneft from more individualized treatment, which can
be done by reducing the risk of OSA consequences on a
patient-to-patient basis.
Motivational interviewing (MI) is a technique that involves
discussing treatment with patients in a way which empowers
them to understand their individual therapy needs and drive
them to address those. Different studies have demonstrated
the usefulness of MI in the CPAP treatment of sleep ap
-
nea
16,17
. Therefore, it is very likely that MI, in combination
with personalized patient interventions, could further improve
adherence.
The main aim of this study is to determine whether OSA
patient adherence to CPAP can be improved using a compre
-
hensive, multidisciplinary programme, based on a motiva
-
tional change model and integration of predictive factors of
adherence, to obtain a specifc patient profle and therefore
a personalized intervention plan. Secondary objectives were
to improve quality of life, emotional state, activities, social
relationships, perceived competence, and motivation.
Materials and methods
Design
A multi-centre randomized, controlled trial (RCT) design
was used, enrolling adult patients with OSA and a prescrip
-
tion for CPAP treatment from the Respiratory Medicine De
-
partment at La Princesa University Hospital (Madrid, Spain),
Joan XXIII University Hospital (Tarragona, Spain) and Central
University Hospital of Asturias (Oviedo, Spain), between May
2018 and June 2019. The study protocol was approved by
the Clinical Research Ethics Committee at the participating
hospitals (N. 3450; N96/19). The clinical trial was registered
with www.clinicaltrials.gov (NCT 04691479).
Patients
The subjects enrolled in the study were required to have
a diagnosis of OSA confrmed by sleep studies with polygra
-
phy and/or polysomnography (criteria of the Spanish Sleep
Society) and be naive to CPAP intervention. The study ex
-
cluded subjects with obesity-related hypoventilation, severe
COPD, cognitive disorders and those unable to understand
the consent to participate. Prior to enrolment in the study, all
patients were informed in detail about the study and signed
the consent form to participate.
The subjects enrolled in the study had to have a diagnosis
of OSA confrmed by sleep studies with polygraphy and/or
polysomnography (criteria of the Spanish Sleep Society) and
be new to the CPAP intervention. The study excluded subjects
with obesity-related hypoventilation, severe COPD, cognitive
disorders, and those who could not understand consent to
participate. Before enrolment in the study, the pulmonolo
-
gists informed the patients in detail about the study, signing
the specifc consent form if they agreed to participate.
Interventions
A process was followed using a random number generator
in SPSS to systematically assign patients to one group or
another, with allocation concealment. The prescribers se
-
quentially included the patients in a spreadsheet that auto
-
matically and randomly assigned the patient to the group
according to the algorithm generated by SPSS. See Figure 1.
Control group patients followed the standard of care.
This standard is set by the Guidelines of the Spanish Society
of Pulmonology and Thoracic Surgery (SEPAR)
19
. Once the
prescription reached the nurse, she would call the patient to
carry out the patient education and training process, which
included the use of CPAP equipment, mask ftting, safety and
maintenance. For follow-up, the patient always went to the
specialized follow-up consultation located in the hospital. The
comparado con el grupo control (90 días) con una diferencia de 1.74 horas/día (IC95% 1.18-2.30) p < 0.0001 y a los 180
días con una diferencia de 2.31 (IC95% 1.72-2.91) p < 0.001. Los resultados secundarios mostraron diferencias signifcativas
a favor del
grupo PIMA.
Conclusiones
. Se encontró evidencia de que un programa basado en estratifcación y planes de atención personalizados,
utilizando entrevistas motivacionales, mejora la adherencia a la CPAP y la calidad de vida.
Palabras clave:
Adherencia; CPAP; Calidad de vida; RCT; Apnea obstructiva del sueño; Estratifcación.
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frequency of visits was days 30, 90 and 180 from the start
of therapy. The follow-up procedure consisted of reviewing
the CPAP hour meter and resolving any incidents themselves,
with the necessary corrective actions. The nurses were spe
-
cialized in CPAP treatment, with experience between 1 and
2 years. They did not receive any special training in com
-
munication skills.
The patients assigned to the intervention group ‘PIMA’
(Spanish acronym: Individualized Adherence Improvement
Plan; Personalized Adherence Improvement Plan) were sum
-
moned by the nurse to start therapy once the prescription
was received. The intervention had 4 steps: a) Stratifcation
to identify the patient’s profle, b) Health education and train
-
ing, c) Evaluation of predictive variables of adherence and
d) Follow-up according to individualized plan.
Stratifcation to identify the patient’s profle
The objective of stratifcation is to identify patient pro
-
fles to which the intervention can best be adapted. For this,
certain personal variables are taken into account: age, ed
-
ucational level, isochrone (the time the patient needs from
home to the care center), use of digital tools (email, etc.)
and service preferences (home visit preferences, calls, spe
-
cialized center ...). The choice of these variables was made
according to the bibliography
15
. For each variable, 4 possi
-
bilities were established, each corresponding to a possible
type of profle: ‘a’, ‘b’, ‘c’ and ‘d’ (Table 1). Together with the
patient, the nurse identifed the alternative that represented
each variable. To know the fnal profle, since there could
be multiple combinations, it was taken into account which
possibilities were repeated the most in each of the 4 possible
profles. In this way, the results are patients with profle ‘a’
(characterized by autonomy and mobility, predisposition to
remote follow-up), patients with profle ‘b’ (need for moder
-
ate intensity in follow-up) or patients with profle ‘c’ (more
mobility diffculties and require more intensive treatment).
Profle ‘d’ was applied to patients who were professional
drivers, as they require specifc interventions based on their
occupation. At this time, the nurse also collected two clini
-
cal variables: AHI (it was taken from the patient’s medical
history) and administered the Epworth Sleepiness Scale
19
.
Health education and training
The intervention for health training and education con
-
sisted of the application of the MEntA (Motivational Interview
for Adherence) program
17
. This program consists of the ap
-
plication of the MI communication technique to the training
of the patient in the treatment of CPAP. For this, the nurses
were trained in MI by a clinical psychologist before starting
the study. MEntA is applied in 2 parts: a part focused on
promoting disease awareness and preparing the patient to
show willingness and interest in treatment, and a second part
focused on the use of the device, mask ft, maintenance and
safety. All the materials used (presentation slides, guides and
manuals…) were adapted to a motivational language. The
duration of this process consisted of 45-55 minutes.
Evaluation of predictive variables for adherence
After training, the nurse evaluated, on the one hand,
the degree of motivation of the patient towards the therapy
and her perceived competence or self-effcacy. To know the
state of motivation, the categorization defned in the trans
-
theoretical model of Prochaska and DiClemente
20
was used,
with a question open to the patient (“
After everything we
have explained to you, how motivated do you feel to start
and follow CPAP treatment?
”) that could be classifed into
fve states: pre-contemplation (very low motivation), con
-
templation (low motivation), determination (somewhat mo
-
Figure 1.
Descriptive diagram of
the interventions.
MEntA:
Educational and Training
Randomized
Training
Program
Follow-up
scheduling
–
Stratification
: identify the
patient's profile
– Assessment of
predictive
variables of
adherence
PIMA group
Control group
– Frequency: D30-D60-D90-D180-D365
– Channel: Home / Care center /
Phone / Telemonitoring
– Action: Adherence evaluation
(Compliance + Epworth +
Perceived Competence + Social
Support + Quality of Life)
Follow-up according to
individualized plan
– Frequency: D30-D90-D180-D365
– Channel: Care center
– Action: Adherence evaluation
(Compliance)
– Corrective actions
– Positive reinforcement
Follow-up according to
Standard of Care plan
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tivated), active change (quite motivated) and maintenance
(high motivation). Regarding the evaluation of perceived
competence, the Validated Perceived Competence Assess
-
ment Questionnaire in Adherence to CPAP in OSA (CEPCA)
was used
21
. The nurse took into account the set of variables
(motivation, perceived competence, OSA severity and symp
-
toms), to ‘predict’ what would be the patient’s adherence
at the start of CPAP therapy. Patients with moderate or high
motivation, a good perception of self-effcacy and signifcant
symptoms were interpreted as a potential high adherence,
and patients with low motivation and poor perception of
self-effcacy were interpreted as risk of low adherence. Those
patients who had only low motivation or only low self-effcacy
were considered to have moderate adherence.
Follow-up according to individualized plan
With the identifcation of the patient’s profle and possible
level of adherence at the beginning of therapy, the individ
-
ualized plan to improve adherence was assigned. Each plan
takes into account how the patient is and depending on how
the level of adherence is, the type of intervention necessary
(Table 1). In the follow-up visits (which depended on the
previous state of adherence and the patient’s profle), the
nurse reviewed the variables of motivation and self-effcacy,
in addition to adherence. After the review, the next visit
was indicated (depending on the level of adherence and
profle). Every time a patient presented low adherence, an
intensive follow-up process with telemonitoring was started.
This confguration allows, on the one hand, the dedication
of resources to patients who need more care, and on the
other hand, the long-term management of large volumes
of patients.
Several outcomes were included in this study. First, ad
-
herence (number of hours of CPAP use/per night) to CPAP
treatment after 90 and 180 days of treatment was assessed
as the primary outcome. The total number of night hours
during which the CPAP device was used at therapeutic pres
-
sure was recorded by specifc counters within each device
and collected during the study follow-up period. In terms of
secondary outcomes, quality of life was assessed using the
Apnea Analog Visual Well-Being Scale
22
(0 is
‘Least favour
-
able well-being status’
and 10 is
‘Most favourable well-be
-
ing status’
) and sleepiness was assessed using the Epworth
Sleepiness Scale
19
. Motivation, as defned in the transthe
-
Table 1.
PIMA Care plans: profle, level of adherence and general interventions.
Profle
High adherenceModerate adherenceLow adherence
aChannels:
Phone-call
Frequencies:*
– Day 30, Day 90
– After 90 days: Every 6
months
Contents:
Positive
motivational reinforcement
Channels:
Phone-call & Care
Center
Frequencies
:
– Day 30, Day 60, Day 90
– After 90 days: Every 90
days
Contents:
Motivational
interview, functional analysis
Channels
: Phone-call & Care
Center
Frequencies
: Every 30
days until change level of
adherence
Contents:
Motivational
interview, training and
educational reinforcement
Telemonitoring
Age< 51 years old
Level studiesHigh-Superior
Digital
Internet, email,
app
Isochrone
Less than 30
minutes
Preference
Remote
bChannels:
Phone-call & Care
Center
Frequencies:
– Day 30, Day 90
– after 90 days: Every 6
months
Contents:
Positive
motivational reinforcement
Channels:
Care Center
Frequencies
:
– Day 30, Day 60, Day 90
– After 90 days: Every 90
days
Contents:
Motivational
interview, functional analysis
Channels
: Care Center
Frequencies
: Every 30
days until change level of
adherence
Contents:
Motivational
interview, training and
educational reinforcement
Telemonitoring
AgeBetween 51 and
65 years old
Level studies
Medium
Digital
Internet
Isochrone
Between 30 and
60 minutes
PreferenceRemote with
Home
cChannels:
Home
Frequencies:
– Day 30, Day 90
– after 90 days: Every 6
months
Contents:
Positive
motivational reinforcement
Channels:
Home
Frequencies
:
– Day 30, Day 60, Day 90
– After 90 days: Every 90
days
Contents:
Motivational
interview, functional analysis
Channels
: Home
Frequencies
: Every 30
days until change level of
adherence
Contents:
Motivational
interview, training and
educational reinforcement
Telemonitoring
AgeMore than 66
years old
Level studiesBasic-Low
Digital
None
Isochrone
More than 60
minutes
PreferenceHome
dChannels:
Care Center
(start), Phone-call (follow-up)
Frequencies:
– Day 30, Day 90
– after 90 days: Every 6
months
Contents:
Positive
motivational reinforcement
Channels:
Care Center
Frequencies
:
– Day 30, Day 60, Day 90
– after 90 days: Every 90
days
Contents:
Motivational
interview, functional analysis
Channels
: Home
Frequencies
: Every 30
days until change level of
adherence
Contents:
Motivational
interview, training and
educational reinforcement
Telemonitoring
Patients who are professional
drivers
*The type of intervention will depend on the patient’s profle and their level of adherence. The patient can change their frequencies and the intervention time
depending on the level of adherence they have at the time of the review. The patient can only change in the 3 possible levels of adherence of his/her profle.
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oretical model
20
, was also assessed by an open question to
the patient, which could be classifed into the fve stages. In
addition, three health-related outcomes (mood, activities,
social relationships) were also measured using the following
ad hoc question ‘
Taking into account your sleep problems,
how would you say you are in terms of mood / activities /
social relationships?
’. The answer alternatives were: ‘2 Good’,
‘1 Normal/no change’, ‘0 Bad’.
Statistical analysis
The sample size was determined based on a previous
moderate effect size of .6 taking into account literature
available with similar characteristics to those proposed in
this study
23
. As such, with an alpha value of .05 and a max
-
imum beta error of .20, a total number of 70 subjects were
established, which was increased considerably in order to
compensate for possible experimental mortality in the study
and to reduce the variability of the measures being studied.
A descriptive analysis of the demographic and clinical
characteristics of all patients enrolled in the study was per
-
formed, as well as a baseline analysis comparing both study
groups after randomization. The statistical inference anal
-
yses were performed using both parametric (t-student for
independent groups) and non-parametric (U-Mann Whitney)
models for continuous variables, and crosstab analysis for
categorical data. The analyses were performed for the com
-
parison of study groups at two cut-off time points (90 and
180 days) and an ad hoc analysis at one year of follow-up
for the most important variables. The Chi-square statistic
was used for comparing all categories at one-year adherence
analysis. The alpha value was 0.05 and all analyses were
performed on two-tails. The statistical software used was
SPSS V26.
Results
Descriptive statistics
Of a total of 257 eligible, 44 patients were excluded for
different reasons (see Figure 2). A total of 213 patients were
randomized between the two groups (PIMA and Control) of
whom 108 were in the intervention group and 105 were in
the control group. 68.1% were men, 58.7% of the study
sample were aged between 51 and 69, and 45.5% had up
-
per-secondary school education. Tests performed to compare
control and PIMA groups at the beginning of the RCT showed
that groups were equivalent for all baseline variables. Table
2 provides descriptive characteristics of the participants.
A total of 9.85% (21 subjects) withdrew from the study.
The percentage of withdrawals in the PIMA group was 10.18%
(11 subjects) while in the control group it was 9.52% (10
subjects). In the PIMA group, the reasons for this were: 8
subjects for clinical reasons (changes of treatment), 2 lost,
1 abandoned. In the control group, 7 patients withdrew be
-
cause of voluntary abandonment and 3 patients were lost.
None of the withdrawals were due to possible adverse effects.
Inferential statistics results
The mean adherence was compared between the study
groups during therapy follow-up. The result showed a statis
-
tically signifcant difference at 90 and 180 days respective
-
ly: 129.24 (IC95% 77.25 - 181.22) p< 0.0001 and 288.30
(IC95% 187.146 - 389.47) p< 0.0001. These results were
also confrmed by non-parametric analysis. Also, the num
-
ber of hours of sleep per day indicated positive results for
the study intervention compared to the control group at 90
days with an improvement of of 1.74 hours per day (IC95%
1.18 - 2.30) p< 0.0001 and at 180 days with an improve
-
Figure 2.
Consort dia
-
gram of participants
randomized to PIMA
and Control Groups.
Analysed (n=96)
Analysed (n=93)
Assessed for eligibility (n=257)
Randomized (n=213)
Allocation
Enrollment
Follow-up
Analysis
– Clinical reasons (n=8)
– Lost (n=2)
– Voluntary abandonment (n=1)
Lost to follow-up (give reasons) (n=11)
– Voluntary abandonment (n=7)
– Lost (n=3)
Lost to follow-up (give reasons) (n=10)
– Received allocated intervention (n=107)
– Did not receive allocated intervention
(Does not attend) (n=1)
Allocated to PIMA Intervention
(n=108)
– Received allocated intervention (n=103)
– Did not receive allocated intervention
(Referred to another specialist) (n=2)
Allocated to Control Group Intervention
(n=105)
– Not meeting inclusion criteria (n=16)
– Declined to participate (n=12)
– Other reasons (n=8)
Excluded (n=44)
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Table 2.
Baseline characteristics of the participants.
Variable
Total sample (n= 213)
PIMA group
(n= 108)Control group (n= 105)
TestdfP
Frequency
(%)
Mean
(SD)
Frequency
(%)
Mean
(SD)
Frequency
(%)
Mean
(SD)
Sex (male)
145 (68.1)72 (66)73 (69.5)
0.2001
.655
Age by groups
1.79
2
.407
< 50 years
53 (24.9)23 (21.30)
30 (28.6)
51-69 years 125 (58.7)65 (60.2)60 (57.1)
> 70 years 35 (16.4)
20 (18.5)15 (14.3)
BMI by categories
4.6956
.584
Normal weight
18 (8.5)
8 (7.4)
10 (9.5)
Overweight62 (29.1)28 (26)
34 (32.4)
Obesity131 (61.5)71 (65.8)60 (57.1)
Missed2 (0.9)1 (0.9)1 (0.9)
Severity OSA
-.922211
.357
Mild
7 (3.3)6 (5.6)
1 (0.9)
Moderate
27 (12.7)
12 (11.1)15 (14.3)
Severe
179 (84)
90 (83.3)89 (84.8)
Apnea-hypopnea index
41.98 (20.28)
40.71 (16.35)43.29 (23.66)
Reason for consultation
2.592
.274
Individual
72
(33.8)41 (38)31 (29.5)
Derivation52(24.4)22 (20.4)30 (28.5)
Familiar surroundings
89(41.8)
45 (41.7)
44 (42)
Quality of life
5.24 (2.23)5.45 (2.30)5.02 (2.14)1.423211
.156
Comorbidity
1.694
3
.638
Physical 122 (57.3)61 (56.5)61 (58.1)
Psychic
11 (5.2)
4 (3.7)7 (7)
None
80 (37.6)
43 (40)
37 (35.2)
Drowsiness 11.57 (5.22)11.61 (5.15)
11.53 (5.31)0.108211.914
Educational levels
2.277
2.320
High-Superior
41 (19.2)25 (23.1)
16 (15.2)
Medium
97 (45.5)
48 (44.4)
49 (46.7)
Low75 (35.2)
35 (32.4)40 (38.1)
Isochrone
2.0452
.360
< 30’196 ( 92.0)99 (91.7)97 (92.4)
30-60’15 (7.0) 7 (6.5) 8 (7.6)
> 60’
2 (0.9)2 (1.9)(0.0)
Use digital tools
0.2232.895
App + email + Internet137 (64.3)68 (63)69 (65.8)
Internet
37 (17.4)19 (17.6)18 (17.1)
None39 (18.3)21 (19.5)
18 (17.1)
Profle
4.537
3.209
66.7
a
64.868.6
22.5b25.020.0
9.4c
7.4
11.4
1.4d2.80.0
Mood
1.461
2.482
Bad
44 (20.7)
20 (18.5)24 (22.9)
Normal/no change126 (59.2)63 (58.3)63 (60)
Good
43 (20.2)25 (23.1)
18 (17.1)
Daily life activities
.977
2
.614
Bad
64 (30)
31 (28.8)33 (31.4)
Normal/no change
111 (52.1)55 (51.1)
56 (53.3)
Good38 (17.8)
22 (20.3)
16 (15.2)
Social relationships
.3012
.860
Bad39 (18.3)20 (18.5)19 (18.1)
Normal/no change145 (68.1)72 (66.7)73 (69.6)
Good29 (13.6)16 (14.9)
13 (12.4)
BMI: Body mass index.
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ment of 2.31 hours per day (IC95% 1.72 - 2.91) p< 0.001.
Moreover, patients in the PIMA group showed an increase
in hours of sleep per day of 0.53 (IC95% 0.032 - 1.04)
p< 0.05 between days 90 and 180, whereas patients in the
control group did not result in increased average sleep per
day between these time points. This was also confrmed by
non-parametric analysis: p < 0.01. Table 3 for complete
results. See Figure 3.
The secondary outcomes also showed statistically sig
-
nifcant improvement for the PIMA group patients for all
measures evaluated. The quality of life at 90 days was 2.56
higher in the PIMA group (IC95% 2.03 - 3.08) p< 0.0001 and
at 180 days was 0.20 higher (IC95% 0.74 - 1.56) p< 0.0001,
see Figure 4. The patient state of mind was evaluated using
three categories and showed that 73 of 102 patients (71.5%)
in the PIMA group reached the best score at 90 days com
-
pared with only 28 of 95 patients (29.5%) in the control
group p< 0.0001 at that same time point. Similar results
were found for daily life activities with 63 and 33 patients
reaching the best category for PIMA and control groups re
-
spectively p< 0.0001. The frequency of social relationships
showed a statistically signifcant difference between groups at
both 90 and 180 days p< 0.0001). Similar results were found
for evaluation of state of mind at 180 days, indicating that
84 patients (85%) in the PIMA group reached the best score
compared with 52 (53.6%) in the control group p< 0.0001.
For daily life activities at 180 days the data showed that
79 out of 99 patients (80%) for PIMA group were active
compared with 53 out of 97 patients (55%) in the control
group p< 0.0001.
It is also interesting to consider communication channels
used for the patient interventions, since this will determine
resources required to provide support. Thus, at 90 days the
use of telephone as the main communication channel was
used by 31.4% of patients in the PIMA group while 64% of
this group preferred a meeting point. On the contrary, for
the control group, all subjects preferred the meeting point
p< 0.0001. However, after 180 days of follow up 96% of
patients in the PIMA group were using the telephone as their
frst communication channel compared with 0% of patients in
the control group p< 0.0001. Also, the number of unsched
-
uled calls during the follow up showed a mean of 0.19 (SD
0.57) for the PIMA patients compared with 0.41 (0.73) those
for control patients, p= 0.003 for non-parametric analysis.
Table 3.
Adherence results for PIMA vs control group.
Variable
PIMAControl
p-valueNMeanSDNMeanSD
Adherence 90 days
101494.812
158.63
95
365.57215.78
< 0.0001
Adherence 180 days97987.608312.71997699.300396.475
< 0.0001
Adherence h/d 90 days
1025.80
1.63
95
4.06
2.28< 0.0001
Adherence h/d 180 days
99
6.33
1.99
97
4.012.23< 0.0001
Change h/d 90 vs 180 days
990.521.8193-0.01
1.73= 0.037
Adherence one year 962161.71864.43871661.21887.22
< 0.0001
Adherence h/d one year 96
5.92
2.3787
4.552.43< 0.0001
Quality of life one year 968.691.66867.67
1.59< 0.0001
h/d: hours per day. SD: standard deviation.
Figure 3.
Adherence. Hours per day at 180 days of follow up.
Figure 4.
Quality of Life at 180 days.
7
6
5
4
3
Hours per day at 180 days
Intervention
Error Bars: 95% CI
ControlPMA
6.33
4.01
9,5
9,0
8,5
8,0
7,5
7,0
QoL at 180 days
Intervention
Error Bars: 95% CI
ControlPMA
8.93
7.77
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The Epworth Somnolence Scale results collected from
patients after180 days a mean difference between groups of
-3.12 (IC95% -3.98 to -2.26) p< 0.0001, with the a mean
value of 2.03 for the PIMA group compared with 5.15 for
the control group. The motivation score for the frst cut-off
showed 49 patients in the PIMA group (45%) were quite
motivated in contrast to 36 patients (34.2%) in the control
group p< 0.001. Evaluation at day 90 showed 75 (73.5%)
patients in maintenance (high motivation) in the PIMA group
compared with 21 patients (22.1%) from the control group
p< 0.0001. Measurement at day 180 showed an increase
in maintenance patients in the PIMA group (85 patients,
85.9%), while for the control group, this fgure only increased
to 25 patients (25.8%), p< 0.0001.
An ad hoc analysis at one year of follow-up still showed
statistically signifcant differences between the PIMA and
control groups for the main variables (Tables 3 and 4). 80%
of patients were compliant at day 365 in the PIMA group
compared with 66.3% in the control group. The improvement
in overall adherence to CPAP therapy in the PIMA interven
-
tion group is clearly demonstrated. At Day 365, the % of
non-compliers in the PIMA and control groups were 20% and
33.7% respectively. The decrease in non-adherence can also
be observed at earlier time-points during the study, where
the % of non-compliers at Day 90 and D180 were 11.8%
compared with 45.7% and 18.2% compared with 38.9% in
the PIMA and control groups respectively. Statistically sig
-
nifcant differences were found in patients with adherence
greater than 6 hours (t [81] = 3.505; p < .001) but not in
patients with adherence between 4 and 6 hours (t [51]) = -.
156; p = .438).
The largest impact of the PIMA intervention on the im
-
provement of adherence to CPAP therapy is observed in the
group of subjects with adherence < 2h/day, more so than
any higher adherence time category. This is also consistent
across all time points.
Discussion
This study has found evidence that a programme based
on stratifcation labels for patients to obtain personalized care
plans, achieves a higher level of effcacy in adherence to the
CPAP intervention, as well as an improvement in quality of
life, emotional state and motivation, when compared to the
standard of care intervention. The data observed in this study
shows how an approach that stratifes OSA patients based
on objective measurements is highly useful in determining
specifc plans according to subject profles and thereby im
-
proves adherence with the CPAP intervention.
The results obtained through clinical trials, which have
been widely discussed, range from increased number of hours
of sleep, quality of life and social relationships, to improve
-
ments in cognitive performance and reduced mortality
24
.
However, the effcacy of CPAP interventions depends on prop
-
er adherence and given its specifc conditions of use. This
aspect still requires a signifcant level of research, since it has
been observed that, in the past 20 years, the percentage of
subjects who do not manage to reach 7 hours of night-time
sleep while using this intervention has remained constant
at around 34% of subjects
23
.
The results of our research show that the stratifcation
procedure, based on which a personalized adherence im
-
provement plan is put in place, is able to maintain adherence
with the therapy for up to 180 days compared to the usual
practice for monitoring this type of patient undergoing CPAP
intervention. The PIMA programme improves therapeutic ad
-
herence by raising patient awareness and adjusting care
to consider changes in their lifestyle and technological ad
-
vances such as telemonitoring
16,25,26
. Previous studies have
shown the importance of examination before prescription,
due to the infuence of anatomical differences in terms of
adherence
27
. It has also been observed that the success of
long-term adherence is conditioned, to a large extent, by
the patient’s behaviour during the frst two weeks
28
together
with the immediate social support they receive
29
. Similarly,
the use of new technologies, such as telemonitoring enables
early intervention with alerts to complications or changes in
use
30
. The use of telemonitoring provides benefts in terms
of adherence, and it seems very useful in situations of early
detection or identifcation of barriers to adherence and to
certain profles that present a specifc clinical picture and
specifc situation
25
.
An important aspect is the cost-beneft impact of an in
-
tervention based on personalization of care. PIMA allows
sustainability since with stratifcation and segmentation, it
is identifed which patients need more attention, without
forgetting the long-term treatment of the rest of the patients.
As a patient’s pattern of adherence is evident within the
frst weeks of CPAP treatment, it is highly likely that patients
have already formed perceptions regarding the seriousness
of OSA and the beneft of treatment, and thus these cogni
-
tions infuence adherence
30
. Education is one way to enhance
self-effcacy. MEntA, the educational program used by the
PIMA programme is based on the motivational interview, for
which there is also extensive evidence on its effcacy in health
Table 4.
Compliance categories for adherence results at one year
Adherence category at day 365PIMA NControl NPIMA (%)Control (%)Difference
≥ 6 h / day
5129
53.7%34.9%
18.8
Adherent
≥ 4 and < 6 h / day
25
2626.3%31.3%
-5
Adherent
≥ 2 and < 4 h / day
14
714.7%8.4%6.3Non-Adherent
< 2 h / day
521
5.3%25.3%
-20
Non-Adherent
Total9583
100%100%
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interventions
26,31
. The factors which the aforementioned stud
-
ies determine as being predictive of proper adherence are
complemented in the PIMA model by the Transtheoretical
Model of Change, in its version adapted to sleep apnoea
treatment, from the initial version created to predict smoking
cessation
32
.
Studies have observed that beliefs related to the pathol
-
ogy or effcacy of the treatment, together with the percep
-
tion of self-effcacy in terms of confdence in starting the
treatment and in beliefs regarding proper interaction with
the environment, explain an up to 30% difference in the
use of the CPAP intervention
33
. A high level of adherence is
associated with an internal locus of control
31
(subjects who
believe they are in control of their own situation are more
likely to take on board the advice provided by the physician)
increasing adherence to CPAP
34
. Motivated patients have a
higher level of adherence to CPAP
35
. This also applies to
subjects with social support, with an improvement in sleep
quality and quality of life also being observed in the person
sharing a bed with the patient
36
. All of these predictive factors
are included in the framework of the PIMA programme and
were used to determine the label for each patient and the
degree of personalization included to monitor them.
The PIMA intervention in our study was based on a broad,
multidisciplinary framework with the aim of personalizing
the approach needed by each patient in terms of improv
-
ing adherence to CPAP. This intervention strives to change
the patient’s perception of the diffculties and drawbacks
of the proposed therapy, as well as their possible risks and
ability to use it. To this end, these results not only show an
improvement in the adherence, but also show statistically
signifcant correlations between this adherence and positive
correlates such as quality of life and activities. Statistically
signifcant relationships were observed between adherence
and patients-reported-outcomes (PROs). These variables are
highly related to the effcacy of the CPAP therapy.
This study has different limitations. First of all, the du
-
ration of it. Although the measurement of some outcomes
in the long term (1 year) has been taken into account, they
have not been measured or a special follow-up has been
carried out between day 180 and day 365. On the other
hand, although the use of digital tools has been taken into
account in the patient’s profle, no intervention has been
carried out that allows us to know if adapting the care plan
to this situation can improve the results. In addition, the
proposal of this program may have little scalability capac
-
ity, given that certain resources are needed (care centers,
contact center...).
Interpretation
The PIMA model summarizes and quantifes the most
relevant aspects to be considered in caring for CPAP therapy
patients. It provides a specifc profle for each patient aiming
to provide personalized care with the help of new information
technologies. Ultimately, this methodology improves OSA
patients’ adherence to CPAP therapy, thereby improving their
quality of life and everyday living conditions. Improvement in
adherence to CPAP therapy leads to an overall lower burden
of disease and decreased costs associated with events arising
from poorly-managed OSA.
Acknowledgements
The research team would like to thank Ana Román
and Jennifer Leonardi from Air Liquide Healthcare for the
resources provided, as well as for reviewing the English
translation of the manuscript. Also to the VitalAire healthcare
staff for their involvement in the study: Verónica Motera
and Patricia Rodríguez.
Financial supports
This work has not received any specifc funding from pu
-
blic sector agencies, commercial sector or non-proft entities.
Author contributions
David Rudilla, Julio Ancochea and Gema Rubinos are re
-
sponsible for the conceptualization of the study. In the design
of the methodology, Pedro Landete, Enrique Zamora and
Maria Vázquez have participated together with David Rudi
-
lla. Those responsible for the validation of the results have
been Julio Ancochea, Salvador Perelló and Gema Rubinos.
Regarding the analyses, David Rudilla and Jose Manuel Tomás
have been responsible. The necessary resources have been
coordinated by David Rudilla and Lluisa Sans. Regarding the
manuscript, David Rudilla, Pedro Landete and María Vázquez
have participated in the drafting of the draft and the revision
and editing. For the fnancing, Julio Ancochea, Gema Rubinos
and David Rudilla have been responsible.
Conficts of interest
The authors declare that they have no confict of interest.
Ethics approval
This study was performed in line with the principles of
the Declaration of Helsinki. Approval was granted by the
Clinical Research Ethics Committee of Hospital Universitario
de La Princesa (N.3450) and Hospital Universitario Central
de Asturias (N96/19).
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